Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

Novartis, Merck See Label Update Successes With FDA

Gleevec (imatinib mesylate) increased overall survival and recurrence-free survival when stomach cancer patients took the drug for three years versus the standard 12 months of treatment following surgical removal of Kit (CD117)-positive gastrointestinal stromal tumors in a postmarket trial.

But not all label update requests are successful. Whether it’s the age-old battle of getting a label approved — or emerging conflicts over postmarket revisions — labeling remains one of the most intense negotiations the drug industry has with the FDA.

Each October an elite group of drug and biologic industry executives, FDA officials, industry attorneys and thought leaders convene at the Third Annual Pharmaceutical Labeling Summit to discuss and debate the future and implications of the ongoing tug-of-war that is pharmaceutical labeling and revision.

Let their expertise help you get the FDA’s OK on your next labeling change! Mark your calendar for the Summit, taking place Oct. 16-17, 2012, in Washington, D.C.